First time study of oxytocin in women when taken via an inhaler
Research type
Research Study
Full title
A single centre, single blind study to investigate the safety, tolerability and pharmacokinetics of single doses of oxytocin (GR121619) administered via an inhaled route in healthy female volunteers.
IRAS ID
183837
Contact name
Disala Fernando
Contact email
Eudract number
2015-001930-10
Duration of Study in the UK
1 years, 0 months, 3 days
Research summary
An oxytocin injection is the recommended treatment for the prevention of heavy bleeding in women who have just given birth. The pharmaceutical company GSK in collaboration with Monash University of Australia is developing a form of oxytocin to take via the Modified Air Inlet ROTAHALER™ dry powder inhaler device (abbreviated IH oxytocin) as a needle-free alternative to injections. This has the potential to save the lives of women in poorer countries, where the lack of a reliable electricity supply can prevent oxytocin injections being stored in a refrigerator.
This is the first time study of IH oxytocin, in approximately 15 non-pregnant healthy female volunteers. It will test how well tolerated are IH oxytocin (50 up to 600 micrograms) and the excipients used in the powder, and measure oxytocin concentration in blood samples, and compare this to the blood concentration of oxytocin after an injection.
Each subject will receive increasing single oral doses of IH oxytocin, and IH excipients, at approximately 24 hours intervals, in 4 separate dosing sessions. On the first day of the first dosing session, the subjects will receive IM oxytocin, approximately 24 hours prior to IH oxytocin or IH excipients. The study doctor with the project team will review study results during the study prior to proceeding with further dosing. When they take an IH dose, the subjects will not know whether they receive IH oxytocin or IH excipients or the dose of oxytocin in each session. The total study duration is up to approximately 20 weeks.
Taking part in the study will not have direct benefit to participants. They will be admitted to GSK’s specialist clinical research unit with adequate safety and compliance facilities for conducting this research. The results of the study will help to plan future studies of IH oxytocin for women giving birth.REC name
HSC REC A
REC reference
15/NI/0147
Date of REC Opinion
4 Aug 2015
REC opinion
Favourable Opinion